Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in… (NCT07610213) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes
Turkey (Türkiye)60 participantsStarted 2027-01-01
Plain-language summary
This study tests a three-phase immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months, with some insulin production remaining).
Phase 1 (weeks 1-2): Teplizumab, an anti-CD3 antibody, is given by infusion to slow immune attack on insulin-producing beta cells.
Phase 2 (months 2-9): Insulin is injected directly into a lymph node (intralymphatic immunotherapy, ILIT) alongside low-dose interleukin-2 to teach the immune system to tolerate insulin and expand protective regulatory T cells.
Phase 3 (months 10-24): Low-dose interleukin-2 is continued to maintain immune tolerance.
The main goal is to preserve the body's remaining insulin production (measured by C-peptide). Sixty adults aged 18-45 will be randomly assigned to the MATIN-2 protocol or standard care. Safety, immune markers, and HbA1c will also be monitored.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-45 years
* Clinical diagnosis of Type 1 diabetes mellitus within 6 months of enrolment
* Positive for at least one diabetes-related autoantibody (GAD65, IA-2, ZnT8, or IAA)
* Detectable fasting or stimulated C-peptide ≥ 0.2 nmol/L
* HbA1c ≤ 10% (86 mmol/mol)
* Ability to provide written informed consent
Exclusion Criteria:
* Prior immunosuppressive therapy within 3 months
* Active or chronic infection (HIV, hepatitis B/C, tuberculosis)
* Current or prior malignancy within 5 years (except non-melanoma skin cancer)
* Pregnancy or breastfeeding
* Severe renal impairment (eGFR \< 30 mL/min/1.73m²)
* Severe hepatic impairment (Child-Pugh C)
* Known hypersensitivity to teplizumab or any excipient
* Participation in another interventional trial within 30 days
* Current systemic corticosteroid or immunomodulatory agent use
* History of other autoimmune disease requiring immunosuppression
* Absolute lymphocyte count \< 1.0 × 10⁹/L
* ALT or AST \> 3× upper limit of normal
* Haemoglobin \< 100 g/L
* Unwillingness to use contraception during study period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.